Perspectives on FDA’s Final Rule on Laboratory Developed Tests:
Understanding the Impacts of IVD Requirements on Test Manufacturers who are Laboratories
About This Resource:
The FDA’s new ruling on Laboratory Developed Tests (LDTs) marks a major shift in regulatory oversight, impacting how clinical labs must navigate in vitro diagnostic (IVD) standards. As LDTs now fall under more stringent requirements, laboratories face new financial, administrative, and operational challenges. This poster breaks down what you need to know about the ruling, including the staged rollout and compliance expectations for 2025 and beyond.
Discover how Velsera’s clinical molecular lab customers can prepare for this transition, understand the specific provisions, and explore common scenarios that could affect your test menu. Download the poster to stay informed and ready for the evolving landscape of LDT regulations.